Method and system for making customized formulations having a thixotropic hydrocolloid for individuals

ABSTRACT

The one or more embodiments disclosed herein provide a method for automatically assembling multiple compounds into a single edible custom composition, in which each compound is individually customized to proportions formulated from a profile of an individual or group. The single custom mixture can contain a plurality of compounds including foods or flavors, nutritional additives, herbals, biologics, or pharmacologically active substances. Using the method and a related algorithm, the formulation of a custom mixture is suggested.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 15/620,915 filed on Jun. 13, 2017, which is acontinuation of U.S. patent application Ser. No. 14/207,364 filed onMar. 12, 2014, which claims priority to U.S. Provisional PatentApplication No. 61/777,181, filed on Mar. 12, 2013, the contents of allof which are hereby incorporated by reference herein.

TECHNICAL FIELD

This disclosure includes a method and system for assembling a subset ofmultiple compounds into a single, edible composition. This disclosureincludes a method and system for assembling multiple compounds into asingle, edible composition, in which each compound is individuallycustomized to proportions formulated from a profile of an individual orgroup.

BACKGROUND

There is a need for customized formulations of dietary supplements andtherapeutics based on the genetic, physical, physiological, and medicalneeds of an individual. Conventionally, typical formulations ofsupplements and therapeutics are prepared as a pill or liquid in batchescomprised of a fixed set of ingredients to be used by the average personwith little regard to the needs of that specific individual. Often timesthese “one size fits all” predetermined formulations containsingredients and quantities that are conflicting with the individual'sneeds and requirements.

As individual genomic sequencing, molecular diagnostics, such as, forexample, laboratory diagnostics or point of care tests, and advancedindividual digital heath testing becomes more economic and prevalent,the fields of pharmacogenomics, nutrigenomics, and metabolomics methodswill likely become more commonly adopted manner of proactive healthcare. These diagnostic advances will drive the need for correspondinginnovation in the formulation and packaging of a range of compounds andbiologics in a small batch production that is economic for individualconsumption. There is a substantial population of individuals withvarious degrees of dysphagia, xerostomia, and other ailments that mayhave difficulty swallowing large and/or numerous pills and tablets andchewing their food properly. In addition individuals with cognitiveimpairment or who are taking a large number of pills need easy to usepackaging that facilitates their ability to manage their daily intake ofdietary supplements and oral therapeutics. These individuals needalternative forms of dietary supplements and therapeutics that allow forease of use. Further, there is recognized need to encourage greaterconsumer compliance in daily intake of key nutritional andpharmacological components in order to obtain desired outcomes, and asolution that uses natural human drives, such as taste and pleasure, ifcombined to suit individual subjective preferences will likely improvevoluntary compliance with prescriptive nutrition and medicine.

A need therefore exists for a method or solution that addresses thesedisadvantages.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription of Illustrative Embodiments. This Summary is not intended toidentify key features or essential features of the claimed subjectmatter, nor is it intended to be used to limit the scope of the claimedsubject matter.

The one or more embodiments disclosed herein provide a method forautomatically assembling multiple components into a single edible customcomposition, in which each component is individually customized toproportions formulated from a profile of an individual or group. Thesingle custom mixture can contain a plurality of components includingfoods or flavors, nutritional additives, herbals, biologics, orpharmacologically active substances. Using the method and a relatedalgorithm, the formulation of a custom mixture is suggested.

According to one or more embodiments, the one or more embodimentsencompass six subsystems. One of the subsystems may include a databaseof the physical parameters of an individual along with several or allvital health conditions, including family history, consumption ofsupplements and pharmaceuticals, and genetic profile of same individual.These may be generated via online questionnaire completed by theindividual or advisor, deciphered from medical or family historyrecords, or results of levels of various compounds as determined bylaboratory tests or in-situ instrumentation or tests and known orsuspected allergens. One of the subsystems includes a database of amultitude of commonly consumed nutritional, biologic, and pharmaceuticalcompounds with normative dose data, contraindications, depletions, andgraded research indicating science evidence correlation score to healthconditions. One of the subsystems may include a formulation algorithmimplemented in software that automatically cross correlates the healthconditions of the individual profile to the compound database selectingthose that are deemed to be recommended and which calculates theratio-metric proportional doses of those selected ingestible compoundsthat correspond to both the appropriate amount and substance for theindividual and their health conditions producing a safe formulation orrecipe for a custom mixture of the multiple selected compounds. One ormore subsystems may include an online computer review process thatallows the user to interact with the recommendation of the formulationalgorithm, to vary within safe limits the amounts of each compound, andwhere desirable or required for safety to obtain a real-time review andapproval by a professional dietician, nutritionists, pharmacist, orlicensed medical practitioner as required. One or more subsystems mayinclude a semi-solid storage and stable media for the compounds selectedsuch that the individual or multi-compounds are suspended in the mediain a uniform and homogeneous distribution throughout the volume of acontainer for the media. One or more subsystems may include anautomation system that converts the formulation recipe for theindividual into a machine sequence for a robotic system that can accesseach of the compound containers of the approved formulation. Thecompound containers are each equipped with a digitally controlledactuator that delivers the precise volume matching the recommended dosevolume of the semi-solid media containing the compound and a digitalmeasuring system to determine amount dispensed to the mixture. Therobotic system then accesses each of the compounds selected in therecipe either sequentially or many compounds concurrently andadministers a homogenization process to blend all of the componentscollected into a single dose ready for packaging or immediate use.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofvarious embodiments, is better understood when read in conjunction withthe appended drawings. For the purposes of illustration, there is shownin the drawings exemplary embodiments; however, the presently disclosedsubject matter is not limited to the specific methods andinstrumentalities disclosed. In the drawings:

FIG. 1 illustrates one or more methods depicted by the flowchartaccording to one or more embodiments disclosed herein;

FIG. 2 illustrates uniform spheres of a supplement embedded into asemi-solid polymer matrix at a known number of spheres per unit ofmeasure according to one or more embodiments disclosed herein;

FIG. 3 illustrates a manner to contain hydrogel suspensions of compoundsin a cylindrical tube constructed of low cost material according to oneor more embodiments disclosed herein;

FIG. 4 illustrates a movable seal at the top end of the tube of FIG. 3according to one or more embodiments disclosed herein;

FIG. 5 illustrates a feeder apparatus according to one or moreembodiments disclosed herein;

FIG. 6 illustrates a feeder apparatus according to one or moreembodiments disclosed herein;

FIG. 7 illustrates a series of feeder apparatuses according to one ormore embodiments disclosed herein;

FIG. 8 illustrates an enlarged, partial view of the feeder apparatusesillustrated in FIG. 7 according to one or more embodiments disclosedherein;

FIG. 9 illustrates transport of assembled compounds according to one ormore embodiments disclosed herein;

FIG. 10 illustrates a flow diagram of one or more methods according toone or more embodiments disclosed herein;

FIG. 11 illustrates a flow diagram of one or more methods according toone or more embodiments disclosed herein;

FIG. 12 illustrates a flow diagram of one or more methods according toone or more embodiments disclosed herein;

FIG. 13 illustrates a flow diagram of one or more methods according toone or more embodiments disclosed herein;

FIG. 14 illustrates a flow diagram of one or more methods according toone or more embodiments disclosed herein;

FIG. 15 illustrates a system diagram of a series of apparatusesaccording to one or more embodiments disclosed herein;

FIG. 16 is a screenshot of an online questionnaire for use with the oneor more systems and methods disclosed herein;

FIG. 17 is a screenshot of a profile for an individual for use with theone or more systems and methods disclosed herein; and

FIG. 18 is a front view of a collection vessel for collecting assembledcompounds according to one or more embodiments disclosed herein.

DETAILED DESCRIPTION

The presently disclosed invention is described with specificity to meetstatutory requirements. However, the description itself is not intendedto limit the scope of this patent. Rather, the inventors havecontemplated that the claimed invention might also be embodied in otherways, to include different steps or elements similar to the onesdescribed in this document, in conjunction with other present or futuretechnologies.

A method to automate a small batch production of dietary nutritionalsand pharmaceuticals is disclosed herein. A combination of methods todeliver a plurality of such compounds is integrated into an automationsolution that enables economic customization at the level of individualneeds and preferences are shown. These automation compatible methodsinclude solutions to a key problem of creating customized formulationsthat include incompatible solubility amongst the plurality of componentsone is mixing. Often ingredients are insoluble in water and must bedissolved in other solvents that are not safe for human consumption. Inaddition mixtures of liquids are unstable, can separate out intoseparate components, form non-homogenous suspensions, and formundesirable interactions. In one or more embodiments, the small batchproduction is less than about 5 liters. In one or more embodiments, thesmall batch production is less than about 1 liter.

One manner of addressing this problem is the creation of semi-solidformulations like hydrogels, organogels, or stable emulsions. Organogelsare a type of gel that is formed from a liquid organic phase and athree-dimensional, cross-linked network.

Thixotropic semi-solids suitable for this purpose will have propertiesthat enable the dissolution or suspension of compounds in a form that isstable until agitated or extruded, at which point the semi-solid becomesfluid and can be dispensed. These thixotropic semisolids which areformed via molecular self assembly of cross-linked polymers, which causethe compounds that are agitated in with the hydro or organogels in aliquid state due to elevated temperature or pH, cause the compounds tobe embedded with a verifiable solution strength and uniform volumetricconcentration of ingredients can act as the components in the buildingof customized formulations. Soluble and non-soluble components may befixed in a tangible semi-solid media such a gelatin, agar, and sodiumalginate. For instance, semi-solid agar embedded with vitamins,minerals, and other nutrients may be used in the practice of growingbacteria. In addition, agar and other hydrocolloids may be used as afood product and may be useful in the delivery of drugs. By usingsemi-solid edible material, one can add a customized quantity and listof ingredients to a container blend these components by using acombination of homogenization, heat, change in pH, or addition ofcations to re-solubilize the semi-solid gels, and then re-form the gelto a desired final edible product. From a combination of these methods,this invention shows a standardized approach to producing semi-solidmatrices that provide a universal compound carrying media that canaccommodate dense, uniformly distributed, and stable over time formsthat are directly amenable to automation.

One or more methods disclosed herein are illustrated with the flowdiagram of FIG. 1, with the method being generally designated 100. Themethod 100 may include receiving health-related information from anindividual 102. This health-related information may be, for example,medical history, height, weight, age, and sex of the individual. One orcombinations of each of these sources of information may be provided.The health-related information may also include family history, geneticinformation, known allergens of the individual, and metabolomic profiledata. This may be provided via laboratory baseline tests. In one or moreembodiments, the individual may be inputting this data onto a computingdevice that is in communication with an external server that controlsthe one or more systems disclosed herein, or this data may be providedby a healthcare service professional.

The method 100 may include receiving taste preference-relatedinformation from the individual. The taste preference related data mayinclude favorite tastes, textures, and dosage size as selected by theindividual. In this manner, if an individual prefers a grape flavoredmedium having moderate viscosity and in a small dosage size, thisinformation would be provided. In one or more embodiments, theindividual may be inputting this data onto a computing device that is incommunication with an external server that controls the one or moresystems disclosed herein.

The method 100 may include, based on the health-related information,determining a suggested formulation for a supplement 106. The suggestedformulation may be certain levels of any given vitamin or nutritionalsupplement that the formulation engine (described in further detailherein) determines is appropriate based on the health-relatedinformation of the individual.

The method 100 may include, based on the taste preference-relatedinformation, determining a suggested filler medium. The suggested fillermedium may be a certain filler material of a given weight, viscosity,taste, and volume as further described herein.

The systems and methods according to one or more embodiments disclosedherein create a customized formulation from data specific to anindividual that facilitates the single dose oral delivery of dietarysupplements, vitamins, therapeutic agents, combined in a highlypalatable custom mixture with food substances, flavors and textures asmay suit the individual tastes. See for example FIGS. 10 and 14. Themethod includes an automated formulation algorithm that uses correlationand relevance scores to create a list of known and available componentsfor inclusion and proportioned dose of each in the custom mixture,derived from data captured in an individual profile. See for exampleFIGS. 11 and 12. The one or more methods illustrated in FIG. 11 combineinformation received from the online questionnaire, medical records andtest results, and also genetic tests to compile a composite individualprofile and preferences score. This individual profile as determineddirectly by a questionnaire, either written and encoded, as onlineresponses to a computer interface, or indirectly by other previouslycaptured data sources specific to the individual, and contains at aminimum the current individual's physical attributes and history datasuch as weight, height, sex, age, and health status, such as pregnant,active, immobile, and the like. See for example FIGS. 11 and 17, withFIG. 17 showing user inputted health related data of a user profile.These basic individual data elements are the parameters of the methodsalgorithm for ratio metric proportioning of the molecular weight of anycomponent to be included in the custom mixture. The individual profilemay also contain a plurality of other relevant data to further refinethe recipe generation, including medical history, family medicalhistory, current nutritional, dietary, and pharmacological productconsumption. The system algorithm of formulation may also incorporateresults of medical test data such as blood pressure, blood sugar, andthe like, or from specific medical condition tests, and/or includinggenetic, proteomic, and metabolomics profiles. The individual's profileis correlated by the system algorithm with a database of a multitude ofconsumable components containing correlation scores for their relevanceto the data captured in the individual profile. This database ofcomponents includes the score for efficacy or applicability to theindividual's profile, as determined by available scientific and otherpublically available data, such as the peer reviewed data from theNational Institute of Health's Office of Dietary Supplements, TheNatural Standard (www.Naturalstandard.Com), Beer's List, and othersimilar available qualified data set. This database on componentattributes supplies the method's algorithm with scores forcontraindications, strength of scientific evidence relative toeffectiveness for specific conditions, and to the individual's profileor to other components, as well as relevant safety precautions ofcomponents taken together. FIG. 16 illustrates a summary chart based onthe correlation score.

As illustrated by the flow chart of FIG. 12, one or more methods 1200disclosed herein may include inputting user profile data 1202. This userprofile data may include the health-related and taste preference-relateddata disclosed herein. The one or more methods 1200 may include crosscorrelating with a compound database 1204 in order to determine suitablenutritional compounds. The one or more methods 1200 may include matchingcompound relevance scores to user factors 1206. The one or more methods1200 may check for durugs taken by the individual/user in order tosupplement interactions 1208. The one or more methods 1200 may includecalculating a dose to individual profile parameters 1210. The one ormore methods 1200 may include presenting a recommendation list andamounts to the individual/user or a professional 1212. The one or moremethods 1200 may include allowing the user to edit and approve of thecompound list 1214. In this manner, if the user wishes to edit theselected supplements being added to a dosage, they may be able to do so.The one or more methods 1200 may include checking for safe levels ofcompounds after user edit to check if the compounds are approved andflag any exceptions requiring further review for approval 1216. The oneor more methods 1200 may include creating and storing customized listdosages with taste subjectives 1218. Further description of steps of theone or more methods 1200 is disclosed herein.

After the formulation algorithm (“FA”) searches the component databaseas keyed by the individual's profile for relevance, efficacy, andcontraindication of all components, the algorithm generates arecommended recipe for the custom mixture. The recipe includes therecommended dose as proportioned to the individual physical parametersand the available dosing information indicated by the manufacturer ofthe component or by the scientific or public data for that component.The recommended recipe of components to include in the custom mixture asdetermined by the FA will be presented to the individual for approval,along with a list of the scores of relevancy, efficacy, and online linksto the publication or reference for each component being recommended, tobe optionally reviewed by the individual consumer. See for example FIG.12. At this point the individual may edit amounts of the recipeformulation, constrained by safe limitations and contraindicationsstored in the compounds database, and if desired augment the formulationwith other desired compounds or taste, texture, and smell components.

In one or more embodiments, a real time tele-present professional, suchas a certified dietician, nutritional counselor, doctor, or otherqualified medical professional, such that an online review may beprovided of the recommended recipe vis-à-vis the individual's profile.This optional step may be provided whenever the FA flags a potentialcontraindication or safety issue. In the case of pharmaceuticalcontraindication, such review would be required by the system andoffered online or in due course after review by a pharmacist, doctor, orother certified and licensed medical counselor. See, for example, FIGS.12 and 13.

FIG. 13 illustrates a flow diagram where a correlated component and dosecalculation, as further described herein, is calculated based on thecompounds scores database, compound dosing and safety data, druginteractions database, and condition depletions.

The individual profile may also include optional flavor, texture, orfood components that are subjectively chosen to bring the custom mixtureto a more palatable and pleasurable state, as may be within the boundsof the volume and media of the custom mixture. This subjective ‘taste’data will be used by the FA to suggest flavor, texture, color, aroma, orother attributes as may be recommended by the algorithm from theavailable filler components that may be added to the end product and asare compatible with the functional components to be used.

In one or more embodiments, supplements will typically be less than 1gram of mass, whereas the ideal mass of the edible supplement pack isbetween about 30 and about 50 grams size when presented as a gel pack.So there is significant volume that can be added along with the activecomponents to improve taste, texture, and other attributes that make theproduct more palatable. As compared to pills, tablets, capsules this isa comparative advantage in ingestibility by parts of the population.

The FA produces a data encoded recipe, which once approved by theindividual consumer and any professional reviewer or licensed revieweras may be required, is stored and logged for that individual order of ancustom mixture. The stored formulation shall include data thatconstitutes the Bill of Materials (“BoM”) required to assemble thecustom mixture, including the list of all components to be included,their mass weights, solution strengths, and calculated volumes. This BoMalso includes the sequence of assembly of the components to the custommixture, using a production database of the components, and a processrecipe that constrains the order of assembly such that the parametersand selection of the individual are produced.

A subsequently applied algorithm, the Process Algorithm (“PA”) uses theBoM to create a machine sequence for automating the sequential orparallel assembly, process control, and quality assurance inline tests,and final homogenization of the custom mixture into an edible form. Thecustom mixture is assembled in accordance with the PA, via a highlyautomated and rapid process from a collection of ingredients that havebeen embedded at a known uniform concentration in semi-solid ediblematerials

The assembled ingredients are then homogenized and/or solubilized andreformed into a desired stable semi-solid form such as a gel,suspension, or emulsion. Individual single servings are then packaged ineasy to use disposable packets with labeling for that individualincluding person's name and date to consume.

In one or more embodiments, at the customer interface, the customerwould be prompted with a series of questions concerning their age, sex,weight, family history of disease, resting pulse, current medications,any current diagnosis disease states, physiological parameters such asblood pressure, recent Ha1C levels, fasting glucose levels, glucoselevels determined from blood glucose meter, cholesterol, HDL, LDL, serumliver enzymes. See, for example, FIG. 11.

In one or more embodiments, the interface would include an interface toinput relevant genetic, metabolomics, proteomic, nutrigenonomic, allergytests and other diagnostic data acquired from individual tests or fromwhole genome sequencing from providers like 23Andme®. Another option forthe customer will be the option to import total personal datasets intothe database from any existing database. Information would be stored ina query able data format such as MySQL. See, for example, FIG. 11.

In one embodiment of the customer interface, the customer will be giventhe option to input taste and texture preferences as compared to otherknown foods. For instance, a preference of sweet, sour, tart, spicy, andsalty and texture preferences such as chewy, crunchy gummy etc.

In one embodiment, the FA will query independent sources such as theNational Standards® database, Beer's List®, and National Institute ofHealth's Office of Dietary Supplements® for potential supplements thatmay have some benefit for the person's current health status based oninput data and provide a list of those ingredients that have been shownby peer reviewed journals to have some level of health benefit. Noclaims of cures for efficacy or will be included in this output thoughreferences to third party public resources may be provided See, forexample, FIG. 12.

In this embodiment the FA will calculate a dose for the desiredingredients by querying a database for appropriate dose based on bodymass, age, sex, and any other known physiological conditions. See, forexample, FIG. 12.

In one or more embodiments, the FA will identify contraindicatingingredients from independent sources such as National Standards®database, Beer's List®, and National Institute of Health's Office ofDietary Supplements® and notifies the customer of the risks. Thecomputer interface may then offer the customer an option to confer witha professional nutritionist or health care provider. See, for example,FIG. 12.

In one or more embodiments, the FA may recommend a flavor and texturecomponents for the individual based on the data from the customer inputinformation.

In one embodiment, a storage media may be provided. The media mayinclude ingredients such as dietary supplements (vitamins, minerals,proteins, amino acids, herbs, micro-dose allergens, and herbal extracts)are embedded at a uniform concentration into three dimensionalsemi-solid polymeric network. Such semi-solid structures are comprisedof polymeric glycosaminoglycans, and polysaccharides like agar,carrageenan, alginate, natural gums, carboxymethyl cellulose, pectin,dextran, dextran derivatives, pullulan, xanthan, xyloglucan, starch,hyaluronic acid, or some combination thereof that exhibit thixotropicproperties. Concentration and composition of polymeric components of thesemi-solid structures may vary between about 0.1% and about 5% (w/w)depending on the final density and pH needed for ingredient addition,storage, and manipulation of semi-solid components.

In another embodiment of a storage media, ingredients such astherapeutic agents (drugs, oral vaccines, and biologics) are embedded ata uniform concentration into three dimensional semi-solid polymericnetwork hydrogels. Such semi-solid structures are comprised of polymericglycosaminoglycans and polysaccharides like agar, carrageenan, alginate,natural gums, carboxymethyl cellulose, pectin, dextran, dextranderivatives, pullulan, xanthan, xyloglucan, starch, hyaluronic acid orsome mixture of the preceding. Concentration and composition ofpolymeric components of the semi-solid structures will vary betweenabout 0.1% and about 5% (w/w) depending on the final density and pHneeded for ingredient addition, storage and manipulation of semi-solidcomponents.

Another embodiment of storage media, is to form uniform spheres ofdietary supplements (vitamins, minerals, proteins, amino acids, herbs,and herbal extracts), fruit and vegetable extracts using the process ofspherification, reverse spherification, or other known encapsulationprocess or microencapsulation methods such as three phase system. Theprocess of spherification has been used been shown to work with othercompositions such as propylene glycol alginate. For example thecombination of several hydrocolloids has been shown to provide a meansto vary key properties such as gelation and physical or chemicalproperties of the resultant hydrocolloid matrix see for example.Composite alginate hydrogels been shown to be useful for the controlledrelease of hydrophobic drugs, and allows solubilization of hydrophobicdrugs. The food trend known as “molecular gastronomy” usesspherification and reverse spherification technique to create uniqueflavors and concentrate food flavors. In this invention the quantity ofthe ingredients in each sphere will be determined using a variety ofmeasurement techniques as needed for that ingredient. The uniformspheres will then be embedded into the semi-solid polymer matrix at aknown number of spheres per unit of measure for example as shown in FIG.2. The mass production of such microspheres of size ranging from a fewmicrons to several millimeter using alginates and processes such asthermal shock of agars produces a means of to capture compounds that arenot soluble in water or other edible liquid, and to produce thesespheres in volume using parallel automation process.

Another embodiment of the storage media is to embed dietary supplementsand therapeutics agents in semi-solid structures containing protein thathas been cross-linked using transglutaminase. This technique to bondproteins together has been used extensively in the commercial foodprocessing industry to create products such products as imitationcrabmeat and fish balls.

The concentration of the ingredients in the semi-solid media will varyfrom between about 1×/mm and about 1000×/ml. For example, if the finaldose is 10 mg and the ingredient is embedded at 10 mg/ml, then theequivalent of 1 ml will be added to the mixture. If the final dose is 10mg and the embedded concentration is 1000 mg/ml, then the equivalent of0.01 ml will be added to mixture.

Final mixture of the components can be achieved by dispersion via adispersion mill, whisking, homogenization, resolublization using heat,adjusting pH, addition of cations, or any combination of these methodsor any other known or known methods for mixing. During the final mixturevarious components necessary to improve flavor, texture, and stabilitywill be adjusted accordingly. Such components include but are notlimited to natural and synthetic flavors, emulsifiers such as lecithin,and stabilizers such as proteins, starch, pectin, plant particles, andof food gums. Final volumes for individual single serving size couldrange from hundreds of millgrams to 100 grams.

Machine and Automation Description

The purpose of the machine and automation design as described herein isto realize the custom mix recipe that is generated by the FormulationAlgorithm into a physical assembly of all the compounds at the correctdose masses and volumes, and to do so with minimal manual interventionso as to be economic relative to convention means of nutritional orpharmaceutical such as pills, powders, and liquids. There are manypotential automation system designs that may be able to produce suchcustom mixtures economically. Conventional approaches have beendescribed using a multitude of precision liquid dispensers but suchmethod have several technical faults, most notably that they co-minglein solution the compounds to be delivered, such that they may interactwith one another prior to ingestion. Such liquid dispensing methods alsosuffer from the ability to accurately dispense a known solution strengthof many compounds, as over time, even a matter of minutes to hours,poorly soluble compounds go through natural gravity inducedsedimentation, such that the active components either become dense todilute from bottom to top of the liquid container, or tend to plate outthe compound on the interior of the containment surfaces due to van derWaal or charge attraction of the materials and compounds. Suchseparation of the compounds from the liquid solution media causesproduction variation in the solution strength that is dispense, suchthat the volume dispensed contains widely varying molecular mass of theactive compound. Such issues can be overcome by the addition ofcontinuous kinetic or thermal energy to the solution, but such designare highly complex, use excessive energy when to maintain uniformsolution strength in a known, state and inherently induce evaporationand thereby change in solution strength of the mixture. This may benotably true of natural, herbal, and lipid solution or oil boundcompounds that cannot readily be held in a liquid suspension that ishomogeneous at known solution strength per unit volume. Further liquidbased solutions are prone to leaks, seepage, and other liabilities thatmay promote microbial contamination, and hence would pose ongoingsanitation requirements and would be more subject to production ofunsafe mixtures.

Similar issues constrain powder based automation solutions, and thesehave other problems that also contribute to the non-uniform distributionof the active compound over the volume to be consumed to assemble thecustom mixture. To overcome these issues, demands a complex andinefficient mechanism and one that that is highly instrumented tomaintain predictable compound strengths as they are processed into thecustom mixture.

Any of the above approaches, as well as others that have been consideredby the inventors and are known to practitioners of such oral deliverysystems, have been rejected not only due to their technical flaws, butbecause of the difficulty that would be inherent in scaling thesedesigns into a system that is economic, secure, sanitary, accurate, andreliable in terms of availability and long times between failure. Theembodiments of the automation system described herein address thesedisadvantages and shortcomings.

Embodiment 1 is illustrated in FIGS. 3 through 9 and is premised on theproduction of a container that has been prefilled with a known solutionstrength of each compound or combination of compounds. FIG. 3illustrates a manner to contain the hydrogel suspensions of compounds ina cylindrical tube 30 constructed of low cost material such aspolycarbonate, polystyrene, glass or other FDA approved materials, suchthat once all the compound is consumed in making custom formulations,this container is economic to dispose of when compared to the cost of areusable container that must be cleaned and refilled. Container 30includes a seal 31 that is actuated by linear motion of the one or moreapparatuses disclosed herein to extrude a precise volume of compoundevenly dispersed in the hydrogel media. The process of filling thecontainer as illustrated in FIG. 3 may use conventional mixingtechniques. For example, the hydrogel media, when in a liquid state, andprior to full cross linking would be dosed with the compound orcompounds of interest and agitated to ensure uniform distribution of thecompound into the suspension. Then the still liquid suspension mixturecan be cast or poured into multiple container tubes at once, soproducing a large number of filled containers in parallel. The filledtube containers may be cooled to the full cross linking temperature ofthe media or otherwise reacted so as to complete the transition to asemi-solid form, such as a gel. The gel strength that is required forthis tubular container, such that it can be accurately dispensed as asemi-solid is a critical variable that will be controlled by thetemperature, pH, viscosity as determined by a viscometer or increasedresistance to stirring as measured by electrical resistance, andhydrogel percentage solution formulation, in accordance with theproperties of the hydrogel media that is used. A similar process mayalso be used to produce multiple tubes in a concurrent batch using batchmixing techniques, containing the hydrogel with suspended microencapsulated containers as illustrated in FIGS. 1 and 2.

In one or more embodiments, the mixture can be centrifuged if compoundsare insoluble to increase solution density at the bottom of tubes. Inthis manner, you could pack insoluble compounds at high concentrations.

Each tube container may be identified and labeled with the name of thecompounds suspended, the solution strength, the date and time ofmanufacture, a serial number identifier, and an estimated shelf lifedate, along with environmental storage requirements includingtemperature range, humidity, light exposure, etc that may affect thephysical or chemical properties of the compound, the media, or thecontainer. Solution strength in milligrams per milliliter for examplefor each compound carrier, along with validation of spectral signaturematch with the intended compound, by a method such as spectrographicmeasurement (RAMAN or mass spec) will be used to produce batch specificlabel information. Such labels will be printed and applied at time ofbatch production, such that they may be transport or stored prior touse. Such labels may contain an optical, RFID, or other manner ofextracting the identity of the tube using an automated reader device andwill be used by the automation system to ensure exact componentidentification and prevent improper incorporation of an ingredient intothe mixture. In one or more embodiments, each tube or batch may have averified solution concentration using analytical methods such as HPLC,MS/GC, raman, light spectrometry, visual inspection, or other.

As shown in FIG. 4, the one or more embodiments contain a movable sealat the top end of the tube. It would be closed at the bottom end with aremovable seal, cap, or filter, which will be removed prior to use. Themovable seal at the top also acts as a plunger that can be actuated in alinear manner to cause a precise amount of the hydrogel suspension to bepushed or extruded from the bottom of the sealed tube when open. Aretention diameter, slightly smaller than the inner diameter of the tubecontainer, at least 0.6% smaller approximately, may be provided by aring such as a rubber “O” ring, which provides enough friction toprevent an uncontrolled extrusion of the media when the tube held in avertical state is opened at the bottom end. This arrangement ensuresthat only once the top seal is actuate in a downward vertical mannerwill any amount of the media be extruded through the marginally smalleropening, thereby making this process under the full control of thelinear actuation mechanism.

Table I shows examples of various tube diameters cross tabulated withpotential solution strengths of compounds when 1 mm (0.039″) of themedia is extruded an relates it to the molecular mass that is containedin this volume. The simple relationship of diameter and length thencontrols the volume, such volume extruded is controlled by length oflinear actuation times π times the most constrained radius squared.

TABLE I Actuator Linear Travel per dose example: 1 mm 0.039 inchDiameter Diameter mg mg mg mg mg mg (in) (mm) 0.01× .1× 1× 10× 100×1000× 0.197 5 0.0079 0.7854 0.7854 7.8540 78.5398 785.3982 0.394 100.0157 1.5708 1.5708 15.7080 157.0796 1570.7963 0.591 15 0.0236 2.35622.3562 23.5619 235.6194 2356.1945 0.787 20 0.0314 3.1416 3.1416 31.4159314.1593 3141.5927 0.984 25 0.0393 3.9270 3.9270 39.2699 392.69913926.9908 0.625 15.87525 0.0249 2.4936 2.4936 24.9364 249.3639 2493.63920.75  19.0515 0.0299 2.9924 2.9924 29.9237 299.2367 2992.3670 19.05

As is indicated in Table I, a lower or higher concentration of themolecular weight of the compound is extruded depending on the solutionstrength that is filled into the tubular container. So a one mm lengthof the media extruded from a 25 mm diameter container yields 0.039milligrams of compound when filled with a 0.1 solution, compared to 39.3mg if the tube is filled with a 10× solution strength. Given the veryhigh density capacity of many of the studied hydrogels, it is possiblefor many highly water soluble compounds to achieve concentration asgreat at 1000×, thereby providing a large capacity of the activecompound in a small cross-section of the tube container. At 10×, a 25 mmdiameter tube that is 250 mm in length could provide up to 5000 doses ofsome compounds that are soluble at this strength. Conversely, a verydilute fill solution would require a much longer length of extrusion,but would inherently allow for microgram accuracy of solutions. Thishydrogel filled container approach allows for dense physical storage formost compounds and provides for several variables that are means tooptimize the storage versus accuracy of the process.

FIG. 5 illustrates a feeder apparatus 50 embodiment of a method wherebythe dispensing of a compound is achieved, in which a precision cuttingknife performs a double purpose of providing an air tight seal for thebottom of the container tube, and an edge 58 for cleaving away a preciselength of the media once it has been extruded to a commanded length. Theknife is controlled by a solenoid actuator 56. An optical photo sensor52 or other non-contact sensor detects start of extrusion and arrow 54indicates the path of component slice that is released. The feedermechanism 50 as illustrated in FIG. 6 has a manner for securing thecontainer tube of FIG. 3 via tube interlock 60, and a manner to attachthe feeder mechanism to a linear actuator 62 at the top of the tube 30,such that the actuator 62 can drive the seal plunger assembly 31 of FIG.4 in the vertical direction. The feeder assembly 50 of FIG. 6incorporated a digitally controllable servo or stepper motor that can becommanded to produce a precise linear actuation in very repeatabledisplacements as commanded by the automation process control system.Each feeder may have a unique identification code or network address, asdoes each physical location that can accept a feeder on the machine.This network architecture enables the modularity of the machine design,allowing feeders conforming to the standard physical and electricalinterface to be substituted for each other, in different locations, butto then identify to the process control algorithm their identity and thecontent of the compound type it holds. Rapid reconfiguration of themachines component inventory is an advantageous aspect of the systemthat allows it to accommodate an ever growing compliance to customformulations, and new inputs. The feeder system, when commanded, willfirst open the bottom of the container tube by retracting the knifeblade cover using a simple actuation such as an electrical solenoid. Theprocess controller will then drive the linear actuator a predetermineddistance that is proportional to the dose amount of the compoundcalculated by the Formulation final and approved recipe and asdetermined by the information conveyed by the label system of the tubecontainer, such that the relationship of linear displacement distance asdetermined by the solution strength and the container diameter isaccurately controlled to the molecular mass demanded in the recipe. Analgorithm or table such as Table 1, embedded in the process automationcontrol algorithm and whose parameters are set by the informationconveyed by the container electronically read tube label produce thecorrect length of extruded compound. A non-contact manner, typically anoptical photo switch, will detect the beginning of extrusion and itsbottom edge, such that the length extruded begins once the detection ofthe bottom edge of the media is true, and then the linear actuator willcontinue to drive till the commanded length has been extruded. The nextstep is that the solenoid that opened the knife edge cover assembly isreleased, and with a rapid and straight parallel motion cleaves thelength of extruded media from that in the container to produce a sliceof component of the commanded length. This actuation of the knife coverwould be performed by a passive mechanical, pneumatic, or magneticforce, such that no electrical or external power is needed to maintainclosure of the tube bottom. The control of the feeder as embodied hereinmay be self-contained and removable or configurable to a machine base.The embodiment would include a local microprocessor controller, that canbe networked with a standard network design, such as USB, CanBus,Ethernet, CAN Ether, RS-485, or other suitable multi-drop serialstandard. The feeder connections to the machine to achieve control asdescribed here may need only be this network connection and power toactuate the linear drive motor, solenoids, and sensors. This approachwill highly facilitate rapid changeover of the machine configuration,allowing very fast setup of a new selection of compound feeders.

The feeder apparatus as shown in FIG. 6 may be implemented as a verycompact unit, such that many such feeders can be arranged in a smallphysical volume. As shown in FIG. 7, many feeders can fit in a shortlinear array, or little more than a meter, or might be arranged in analternative configuration of a compact orbital fashion around a SCARA orother rotary actuator robot. FIG. 7 shows a linear configured robot 70of a very simple design that integrates a number of feeders as describedabove onto a common frame. The main robotic linear axis 74 shown in FIG.8 is driven by a similar servo of stepper controlled linear actuator 78as is used by the compound feeders. The moving carriage on the roboticactuator carries a collection vessel 72 along guides 76 to catch andcollate the output of each feeder as it completes the sequence describedabove, and as instructed by the process controller with an assemblysequence as diagrammed in FIG. 15. The collection vessel 72, for examplesuch as FIG. 18, may include a stainless mesh basket 184 to catchcleaved component slices and may be augmented with vacuum suction 82 soto assure that the cleaved length of media cut from the feeder will becollected positively. This is an important innovation in that some ofthe solutions strengths might result in very thin slices being cleaved,where the material is dispensed according to directional arrow 82, suchthat they have light mass and may not fall directly down, but drift inthe air laterally if not assisted. The vacuum pull of the collectionvessel will begin operating just before the knife cover closes so at toobtain control of the output slice, until that slice has fallen into theinterior of the collection vessel. The bottom of the collection vesselmay contain a precision strain bridge to weight the resultant sliver,and that weight that is detected will be compared by the process controlsystem to the expected weight of the added media. If this weight doesnot correspond, then the vessel will be able to eject the output andcommand a retry of the feeder. Once a successful mass of the compound isverified to be in the collection vessel, the robot actuator will becommanded to travel to the location of the next feeder from which acontribution of component is commanded. This process repeats until allthe compounds have been collected that are specified in the custom mixrecipe.

Once the full collection of the component compounds is completed byaccessing all of the demanded feeders, then the robotic actuator willtake the collection vessel 72 to a station above a device forhomogenization and blending of the assembled compounds 94, as shown inFIG. 9. A door for the homogenizer unit 90, effectively a blender, willautomatically be opened by a commanded solenoid, and the entire contentsof the containment vessel will be emptied under vacuum and air blastinto the homogenizer chamber. Once the collection vessel is emptied, thehomogenizer door closes and the process of blending and macerating theassembly commences. A valve will meter from another source, a volume ofliquid, gel, or semi-solid into the homogenizer chamber containing otherfiller or nutritional materials 92 in a calculated volume to make thedesired total volume for the individual serving package for a single dayor the multiple serving packages to a total volume for multiple days.This input filler may be an organic liquid, for example fruit juices orextracts, gelled edible composites, semisolid, or just added water andmay contain flavors, textures, and the like intended to make theresultant compound more palatable. A similar system may feed this inputto accommodate the taste preferences captured in the profile. Thehomogenizer 90 blends, macerates, and turns all inputs into a consistentproduct via direction arrow 94, to the extent that this process producesa desirable product, under control of time, speed of blending, form ofmaceration tool, or cutting blades, as may be suited to the algorithmscontrolling the process automation and optimization based on thecombined properties of the known inputs to the mixture, for example tomake the output “chunky” or “smooth” or any variant of textures.

After homogenization and volume completion in this step, the effluent ofthe homogenizer is ejected through a valve and is now ready forpackaging into the edible consumable format. FIG. 14 diagrams thecomponents of the post assembly homogenization step that results ineither a single or multiple volume edible product of the customformulation. The homogenizer/blender 90 receives material formed fromcomponent slices, filler to fill out the package volume, and flavor andtexture components. The homogenizer/blender then forms a single customdose.

Multiple lines such as shown in FIG. 7 can be combined parallel,concurrent production to increase the number of online compounds orcomponents. In one embodiment that uses the inherent modularity, theoutput of two or more such lines into a common homogenizer would providea manner to have a larger number of components simultaneously online,with the impact of a dramatic reduction in machine configuration setuptime. For example, a line with 24 components combined with another of 24components would have an online inventory of 48 components that can beused in the formulation required, without any machine and feederreconfiguration. This approach would also support multiple homogenizers,and with basic plumbing, the outputs and inputs of the lines can becombined to produce a larger and more rapidly created input for thepackaging process.

In another embodiment, a similar feeder for the compounds is used in away that these feeders are accessed concurrently and in parallel, suchthat all components needed to make the formulation are dispensed in thespecified proportions into a carrier medium, such that the filler mediathat makes up much of the output of the edible product. This approachwould have potential of a very high throughput when compared to thesequential assembly process using the robotic collector approach of thefirst discussed embodiment. This embodiment would have advantages inspeed at the cost of greater complexity of plumbing the flows. Whilesharing a common implementation of the FA, the process algorithm wouldbe significantly different as regards machine control. Thehomogenization process would be similar to the one in the firstimplementation, but would combine the parallel flows from the feederwith the filler in final step before packaging.

In another embodiment of the automation, the feeder mechanism as shownin FIG. 6 is replaced by a tape feed device similar to that used in highspeed surface mount electronics assembly. The dietary supplement ortherapeutic agent in this system would be enmeshed in a hydrocolloidmatrix as per the description above, but with a formulation of thehydrocolloid such that is it suitable for post gel formationdesiccation, removing some or all of the water content. The effect ofdesiccation of the compound bearing a hydrogel formulation would be toshrink its volume and also to make the component more physically rigidand stable to enable packaging and handling of it by automation, akin to“pick and place” SMD assembly machines. Such componentization of thecompounds in SMD sized formats would allow for large online inventoriesof components. By varying the volume and the solution strength of thecompound enmeshed with the hydrogel, a large range of quantized dosescan be predefined, produced, and packaged in this way. The advantage ofthis approach would be to further reduce the space of storage of a largevariety of pre-packaged components, but at the expense of further stepsto dessicate, cut, and package the component, as compared to the tubefeeder method shown in FIG. 6. This method may not be very applicable tocompounds that need to be supplied dissolved in lipids and/or oils orthat require viability of the materials in biological forms (biologics,live vaccines, stem cells, etc) and so require retention of water in thepackaging. Also the cost of formulating, forming, and packaging thepre-defined doses on tape is considerably more expensive and demands ahigh knowledge of the user rates of consumption to justify theinvestment.

Another embodiment that has potential for high volume customization isto use the techniques as learned from the 3D printing technologies. Alsoknown as 3D lithography, this technology is directed at the productionof discrete artifacts and parts made of plastic, polymer, or sinteredmetal whose shape is determined by a Computer Aided Design data set todriving a printer style machine that builds up the specified design invertical stratification. Some of these principles can be applied to thecustom formulation of nutraceuticals or pharmaceuticals as an embodimentof the subject matter disclosed herein. A hydrogel or digestiblepolymers can be loaded with known solution strength of active compoundsand then extruded as a mononfilament cable or string. This string canthen be cut to length to arrive at a specified dose. In this embodiment,the monofilament dietary supplement or therapeutic agents filled stringbecome a continuous cylinder like that of FIG. 6. This method of feedingcomponents as monofilament polymer matrix with embedded active compoundshas advantages in the formation of other non-oral feeding methods such asuppositories where 3D shape may be important, or implantable prostheticdevices with active drug release. This approach would enableminiaturization to make very small machine system feed by spools orcassettes or print cartridges containing the components with the samefunctionality of variable input of active compound level to a custommix.

Packaging

In an embodiment the final mixture will be dispensed in a disposablepacket, bottle, cup, or other container which will be labeled withperson's name, date to use, flavor and other pertinent informationindicating a customized formulation. This approach will aid complianceand give clear labeling of contents for end users.

According to one or more embodiments, a system is provided. The systemincludes a computing device configured to receive health-relatedinformation from one of an individual, their agent, or a serviceprovider, receive taste-related preference data from a individual, basedon the health-related information, determine a formulation for asupplement for the individual, and based on the taste-related preferencedata, determine a filler medium that is consistent with thetaste-related preference data. The system further includes a formulationmodule configured to prepare the formulation, a medium formulationmodule configured to prepare the filler medium, and a dispenserconfigured to dispense a predetermined amount of the formulation withinthe filler medium to form a dosage.

According to one or more embodiments, health-related informationincludes one of medical history, height, weight, age, and sex of theindividual. Health-related information may include family history,genetic, allergy profile, and metabolomic profile data of theindividual.

According to one or more embodiments, taste-related preference dataincludes taste, texture, and size of dosage.

According to one or more embodiments, the filler material is semi-solidand/or edible.

According to one or more embodiments, the filler material is ahydrocolloid.

According to one or more embodiments, the filler material is anutritional filler.

According to one or more embodiments, the formulation includes multiplecomponents of compounds.

According to one or more embodiments, the dosage is configured as adaily dosage.

According to one or more embodiments, the dispenser is configured todispense the formulation in uniformly distributed manner.

According to one or more embodiments, the system further includes aserver in communication with the computing device that includes a databank having individual parameters affecting dosing levels. Theindividual parameters include age, sex, body mass, circumstantial healthstatus, laboratory tests of levels of compounds onboard, and currentconsumption level of compounds.

According to one or more embodiments, the system includes a server incommunication with the computing device that includes a data bank havingavailable compounds that have associated scores of relevancy, efficacy,and safety in relation to the health-related information from theindividual.

According to one or more embodiments, the computing device is configuredto determine appropriate dosing requirements based on the health-relatedinformation of the individual. The health-related information includesones of age, sex, body mass, circumstantial health status, and currentconsumption level of compounds.

According to one or more embodiments, the dispenser uses at least one ofcontrolled actuation, pressure, compression, and displacement todetermine a desired mass or volume of the formulation within a dosage.

According to one or more embodiments, the computing device is configuredto determine a molecular mass of formulation, and further wherein thedispenser is configured to dispense the determined molecular mass offormulation.

According to one or more embodiments, the formulation module may includeone or more containers having a formulation therein, and the computingdevice may be configured to compare an electronic identification of eachof the containers and a desired formulation.

According to one or more embodiments, the formulation module isconfigured to prepare the formulation from a plurality of compounds.

According to one or more embodiments, the computing device is configuredto determine a pattern for a given individual in which multiple dosesare ingested daily and based on the pattern, determine a formulationthat includes the multiple doses. The dispenser is configured todispense the formulation that includes the multiple doses into a singlefiller medium for a given day of dosages. In this manner, health-relateddata could be monitored as a person consumes the one or morecompounds/supplements provided herein. As one example, if a person hadlow iron levels before ingesting the supplement, a first elevated ironlevel could be mixed with a compound. After a period of treatment, theperson's health information could be monitored, and if iron levels werethen at normal levels, a lower amount of iron could be mixed with theformulation.

While the embodiments have been described in connection with thepreferred embodiments of the various figures, it is to be understoodthat other similar embodiments may be used or modifications andadditions may be made to the described embodiment for performing thesame function without deviating therefrom. Therefore, the disclosedembodiments should not be limited to any single embodiment, but rathershould be construed in breadth and scope in accordance with the appendedclaims.

What is claimed:
 1. A system comprising: a computing device configuredto: receive health-related information from an individual; receivetaste-related preference data from a individual; based on thehealth-related information, determine a suggested formulation for asupplement for the individual; based on the taste-related preferencedata, determine a suggested filler medium; receive individualalterations to each of the suggested formulation and suggested fillermedium.